Stockwinners Market Radar for November 10, 2017 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

17:12 EDT Mattel up 23.5% after WSJ says Hasbro makes takeover approach

16:50 EDT Mylan announces voluntary delisting from TASE - Mylan (MYL) announced that it is voluntarily delisting the company's ordinary shares from trading on the Tel Aviv Stock Exchange. Under Israeli law, the delisting of Mylan's ordinary shares from the TASE will become effective in three months, on Feb. 12, 2018. When Mylan first listed its shares on the TASE in November 2015, in connection with its attempt to acquire Perrigo (PRGO), it committed to maintaining the listing for at least one year. Mylan has been listed on the TASE for more than two years. Mylan's shares will continue to be listed on the NASDAQ, and all of its ordinary shares now traded on the TASE may be transferred to the NASDAQ.

16:18 EDT CombiMatrix holders approve merger pact with Invitae - CombiMatrix (CBMX) announced that, based upon the final vote count for the company's Special Meeting of Stockholders held today, a majority of its stockholders voted to approve the previously announced merger agreement with Invitae Corporation (NVTA), pursuant to which the company would become a wholly owned subsidiary of Invitae upon closing of the proposed merger. Approximately 1.79M of the common shares voting at today's Special Meeting voted in favor of the approval and adoption of the all-stock merger agreement, which represented approximately 60.8% of CombiMatrix's total outstanding shares of common stock as of the September 26, 2017 record date for the Special Meeting.

13:39 EDT Sage Therapeutics CEO says 'we intend to keep doing this by ourselves' - Asked about his company's plans after two studies of brexanolone in the treatment of severe and moderate postpartum depression each hit their primary endpoint, Sage Therapeutics CEO Jeffrey Jonas said during an interview on CNBC: "We've done all of this by ourselves and we intend to keep doing this by ourselves."

13:10 EDT Four Corners Property Trust increases quarterly dividend 13% - Four Corners Property Trust announced that its board declared a quarterly cash dividend of 27.5c per share for Q4. This represents an over 13% increase from the prior quarter. The dividend is payable on January 12, 2018 to shareholders of record as of December 29, 2017.

12:57 EDT Box Office Battle: 'Thor: Ragnarok' expected to hold top spot - Disney's (DIS) latest Marvel superhero spectacular, "Thor: Ragnarok," starring Chris Hemsworth and Mark Ruffalo. is expected to again win the box office this weekend, its second in theaters. It is expected to earn an additional $54M-$57M domestically this weekend, following up its $122.7M domestic opening last weekend. Opening this weekend are 21st Century Fox's (FOX, FOXA) "Murder on the Orient Express" and Viacom (VIA, VIAB) subsidiary Paramount's "Daddy's Home 2," which pulled in $1.6M and $1.5M in Thursday night previews, respectively. Agatha Christie mystery adaptation "Murder on the Orient Express," directed by Kenneth Branagh and starring an ensemble cast, is expected to open in the $20M-$24M range, with the Thursday night preview numbers making the higher end more likely. Holiday comedy "Daddy's Home 2," starring Mark Wahlberg and Will Ferrell, is expected to open in the $20M-$23.5M range. STX Entertainment's "A Bad Moms Christmas," is expected to deliver between $9M-$10M in its second weekend at theaters. Other publicly traded companies in filmmaking include Comcast (CMCSA, CMCSK), Lionsgate (LGF.A, LGF.B), Sony (SNE), and Time Warner (TWX).

12:30 EDT Alibaba reports Singles Day GMV has exceeded $10B - In a post to its corporate live blog of the 11.11 Global Shopping Festival, Alibaba staff reported that at 1:06:09 a.m. local time total GMV exceeded $10B, adding that 92% of that was from mobile transactions. Reference Link

12:20 EDT The Intersection: Crypto and Wall Street This Week - As bitcoin, ethereum and other cryptocurrencies get increasing attention from investors, Wall Street and its traditional banks continue to adjust to the shift. Catch up on this week's top stories highlighting the intersection of these old guard and new school areas of finance with this recap compiled by The Fly: 1. NVIDIA COMMENTS: Cryptocurrency revenues have been pointed to as reasons to be bullish on Advanced Micro Devices (AMD) and Nvidia (NVDA) in select research. In an earnings call on Thursday, Nvidia reported that revenue from crypto-related products fell to $70M in the third quarter from $150M in the prior period. "Crypto is small for us but not zero, and I believe that crypto will be around for some time," Nvidia CEO Jensen Huang said. 2. DEVELOPERS SUSPEND FORK PLANS: On Wednesday, a coalition of developers suspended plans for the "Segwit2x" software upgrade that could have split the bitcoin currency in two as the upgrade could "divide the community," Reuters reports. SegWit2x, which had aimed to improve the bitcoin network's transaction capacity, received significant support when announced but many developers withdrew that support over the last several months. "Our goal has always been a smooth upgrade for bitcoin," lead developer of the upgrade team and BitGo CEO Mike Belshe said. "Although we strongly believe in the need for a larger blocksize, there is something we believe is even more important: keeping the community together." 3. GOLDMAN SEES CONSOLIDATION AT $8,000, THEN HIGHER: In a note to investors on Sunday, Goldman Sachs vice president Sheba Jafari predicted consolidation will occur when bitcoin reaches $8,000. "The market has shown evidence of an impulsive rally since breaking above $6,044. Next in focus $7,941. Might consolidate there before continuing higher," she wrote. While Goldman warned against traders expecting a rapid increase past $8,000, Jafari referenced the Elliott Wave Theory saying, "Given that this is just a third of five waves up, the implications are that bitcoin has potential to run further over time." 4. CME SEES ASSET CLASS: On Tuesday, CME Group (CME) chairman emeritus Leo Melamed said bitcoin is likely to become a new asset class, like gold or stocks, to be traded by investors and regulated, Reuters reported. The remarks come after CME announced it would launch bitcoin futures contracts by year-end allowing investors to short-sell the cryptocurrency and enabling two-way bets, which Melamed believes will attract major institutional investors. "That's a very important step for bitcoin's history... We will regulate, make bitcoin not wild, nor wilder. We'll tame it into a regular type instrument of trade with rules," he said. 5. CBOE SEES BITCOIN ETFS: In an earnings call on Tuesday, CBOE Global Markets (CBOE) president Chris Concannon said, "With regulated futures of a certain asset class like a bitcoin, you do have an opportunity to introduce ETFs and over time we do envision ETFs coming to market once the regulated futures market is dealt and liquid." The Chicago-based exchange operator is competing with CME to launch bitcoin futures, announcing in August it aimed to offer the contracts by year-end or early next year. CBOE's CEO and chairman Ed Tilly said it's "not surprising CME recognizes the same benefits of offering a transparent market." 6. BITCOIN BEARS: "Dr. Doom" economist Nouriel Roubini, who predicted the 2008 financial crisis, said he believes bitcoin is a bubble, Business Insider reported on Wednesday. "In my opinion, there is a gigantic speculative bubble related to the bitcoin," he said. "Because this is neither a serious method of payment nor a good way to store capital. The bitcoin feeds on itself. There are no fundamental reasons for its price to reach such levels. What's more - it is also used by criminals, for their shady business. I think that more and more countries will start to make cryptocurrency exchanges illegal like China did. New regulations will be adopted. So, this will find its end." In addition, Societe Generale (SCGLY) CEO Frederic Oudea said on Tuesday that while he supports distributed ledger technology, cryptocurrencies hold too much risk due to their anonymity, CNBC reports. Oudea said, "I can't see a future of this when I see the attention played by all governments and regulators on anti-money laundering, on anti-tax evasion, on anti-terrorism financing. The anonymity of the transaction is a problem I think which would put pressure on bitcoin." PRICE ACTION: As of time of writing, bitcoin fell about 5.4% this week, or $395, to $6,896 in U.S. dollars according to CoinDesk. Meanwhile, AMD shares rose 1.5% to $11.29 this week and Nvidia was up 4.5% on a weekly basis to $218.42. Bitcoin Investment Trust (GBTC) dropped 5.5% this week to $906. WANT BITCOIN NEWS ALERTS?: To receive alerts on stories relating to bitcoin and other cryptocurrencies, Fly subscribers can enter "Bitcoin" into the "Add symbols" box of their portfolios.

12:04 EDT Pfizer sells 49% stake in Hisun-Pfizer Pharmaceuticals joint venture - Pfizer and Zhejiang Hisun Pharmaceuticals announced that Pfizer has sold its 49% equity share in its joint venture, Hisun-Pfizer Pharmaceuticals Co., Ltd. to Sapphire I Holdings Limited. Hisun-Pfizer Pharmaceuticals Co., Ltd. is a joint venture formed by Pfizer and Hisun in 2012 to develop, manufacture and commercialize branded generic pharmaceutical products in China and global markets. The transfer of Pfizer's equity stake will allow both Hisun and Pfizer to focus on their core strengths. After Pfizer's equity share transfer, the joint venture will change its name but will retain its current rights to manufacture, sell and distribute all of Hisun-Pfizer Pharmaceutical's currently marketed and pipeline products in China. Pfizer will continue to support a technology transfer process to ensure that the products that had previously been licensed to Hisun-Pfizer Pharmaceuticals by Pfizer, will in the future, be manufactured locally in China. Pfizer will continue to supply certain products to the joint venture for a period of time, after closing, to facilitate a smooth transition. Pfizer and Hisun will maintain a strong and collaborative relationship, providing for the ongoing supply of high-quality generic products to patients in China through the joint venture.

11:35 EDT Medical device makers fall after Citi says Amazon coming soon - Amazon.com (AMZN) is likely further ahead in accessing the medical supply chain than it is within other parts of healthcare, Citi analyst Amit Hazan told investors earlier in a research note titled "Amazon: Coming for Medtech Sooner Than You Think." The analyst believes Amazon is working with an advisory board of at least 12 large hospital systems who in total represent 5%-8% of supply purchases in the U.S. Hazan sees a high likelihood that one or more major hospital systems could announce Amazon as their distributor in the near term. Makers of medical devices are trading lower in midday trading, with Baxter (BAX), Becton Dickinson (BDX), Boston Scientific (BSX), Medtronic (MDT), Stryker (SYK) and Zimmer Biomet (ZBH) all in the red by over 1.5%. Hazan says that hospital systems he spoke to were "overwhelmingly positive" towards an Amazon entry. A number of entities predicted 20%-30% of their medical supply purchases could move to Amazon distribution within the next 24 months, Hazan wrote. healthcare i distributors Cardinal Health (CAH) and McKesson (MCK) are also trading lower in today's trading while AmerisourceBergen (ABC) is up 58c to $75.83.

11:33 EDT Arena Pharmaceuticals completes full enrollment in Etrasimod Phase 2 study - Arena Pharmaceuticals announced that it has completed full enrollment in the etrasimod Phase 2 study in ulcerative colitis. Etrasimod is an investigational-stage, oral, next-generation, sphingosine-1-phosphate receptor modulator with improved pharmacology and pharmacokinetics intended for the treatment of autoimmune diseases. The study enrolled 157 patients at sites globally. The study is a 12-week, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging trial evaluating safety and tolerability. Efficacy endpoints include improvement in the Mayo clinical score, response, remission and mucosal healing versus placebo, and dose response. The study enrolled patients with moderate to severe UC.

11:22 EDT Assurant raises dividend by to 56c from 53c per share - Assurant announced that its board of directors approved a quarterly dividend increase of 3c to 56c per share of common stock. The dividend will be payable on Dec. 18 to stockholders of record as of the close of business on Nov. 27.

10:58 EDT Inovio: MEDI0457 led to complete response with PD-1 checkpoint inhibitor - Inovio Pharmaceuticals (INO) announced that two of its cancer immunotherapies demonstrated antigen-specific T-cell stimulation in phase 1 studies. INO-3112, now called MEDI0457, an investigational T-cell activation immunotherapy that targets cancers caused by human papillomavirus types 16 and 18 and licensed to MedImmune, the global Research and Development arm of AstraZeneca (AZN), also led to a head and neck cancer patient's complete response when matched with a PD-1 checkpoint inhibitor. In addition, INO-1400, Inovio's investigational cancer immunotherapy targeting hTERT, which is over-expressed in a majority of cancers, generated hTERT-specific IFN-gamma secreting T cells, suggesting an ability to break immune tolerance. These results were revealed at poster presentations at the Society for Immunotherapy of Cancer 32nd Annual Meeting starting today at National Harbor, Md. In a phase 1 study of MEDI0457 in 22 HPV-positive patients with squamous cell carcinoma of the head and neck, Inovio has previously demonstrated that this cancer immunotherapy generated robust antigen-specific CD8+ killer T cell responses in both tumor tissue and peripheral blood. One patient which initially displayed a slight increase in T cell immune responses developed progressive disease at 11 months into the study and received nivolumab, a PD-1 checkpoint inhibitor. Subsequently, the patient had a sustained complete response after only four doses, and continues on therapy with no evidence of disease, 16 months after initiation of nivolumab. Detailed immune analyses found that MEDI0457 had activated HPV16-specific CD8+ T cells in the patient and the subsequent treatment with nivolumab helped to unleash the expansion of these killer T cells, which is contributing to the sustained complete response observed in this patient. Medimmune is conducting a separate phase 1/2 trial combining its PD-L1 inhibitor with MEDI0457 in HPV-associated head and neck cancer patients to evaluate the clinical efficacy of the combination treatment.

10:55 EDT Houston American Energy trading resumes

10:48 EDT Grainger reiterates LT operating margin target of 12%-13% in 2019 - Grainger reiterated its longer term operating margin target of 12%=13% in 2019, excluding items that the company believes are not indicative of ongoing operations.

10:34 EDT Houston American Energy trading halted, news pending

10:11 EDT Rexahn treatment of pancreatic cancer granted orphan designation in EU - Reference Link

09:50 EDT Liberty Expedia Holdings (Series B) trading resumes

09:45 EDT Liberty Expedia Holdings (Series B) trading halted, volatility trading pause

09:27 EDT Teligent announces FDA approval of Betamethasone Dipropionate Ointment USP - Teligent announced it has received approval of the company's abbreviated new drug application, or ANDA, from the FDA of Betamethasone Dipropionate Ointment USP, 0.05%. This is Teligent's seventh approval for 2017, and its seventeenth approval from its internally-developed pipeline of topical generic pharmaceutical medicines. Based on recent QuintilesIMS Health data from September 2017, the total addressable market for this product is approximately $43.3M.

09:13 EDT Eros International expands content availability globally with LG smart TVs - Eros International announced that Eros Now, its cutting-edge digital over-the-top South Asian entertainment platform, will be available on webOS enabled LG smart TVs worldwide with a preferred placement for the Eros Now app in the devices in India. Eros Now's vast library of Bollywood and regional language films, music videos, TV shows, originals and more will be accessible by millions of LG smart TV owners across the globe. Users will also be able to enjoy a range of exciting features including full length movies, thematic curated playlists, multi-language subtitles for movies, music video playlists, regional language filters, and access to a watch list of titles.

09:11 EDT J.C. Penney says not going to take aggressive inventory liquidity actions in Q4

09:05 EDT Equifax sees Q4 charge of $60M-$75M due to cybersecurity incident

09:04 EDT Blueprint Medicines reports new Phase 1 data of BLU-285 - Blueprint Medicines announced new Phase 1 clinical data for BLU-285, a highly selective KIT and PDGFRalpha inhibitor in development as a potential treatment for patients with advanced gastrointestinal stromal tumors, or GIST. The data confirm and build upon data previously presented for BLU-285 in patients with advanced GIST. The data showed 67% of patients with heavily pretreated KIT-driven GIST treated with 300 to 400 mg of BLU-285 once daily had radiographic tumor reductions. In this population, the data also showed an objective response rate of 17% and median progression free survival of 11.5 months. In patients with PDGFRalpha-D842 driven GIST, the data showed an ORR of 71% and an estimated 12-month PFS of 78 percent. BLU-285 was well-tolerated. Blueprint Medicines plans to pursue expedited development of BLU-285 in patients with PDGFRalpha D842V-driven GIST, and the company is on track to initiate a global, randomized Phase 3 clinical trial of BLU-285 in third-line GIST in 1H18, with the goal of supporting registration of BLU-285 in a broader GIST patient population.

09:03 EDT Equifax sees 'significant' one-time costs in Q4 due to cybersecurity incident

08:56 EDT J.C. Penney CEO says adding adidas to nearly 200 more stores this holiday season

08:53 EDT Equifax says cybersecurity incident negatively impacted Q3 revenue by 1%-2%

08:49 EDT J.C. Penney sees ongoing margin initiatives positively impacting selling margins - CFO Jeff Davis said that for Q4, it expects ongoing margin initiatives to have a positive impact on selling margins as benefits are realized in areas such as pricing analytics and improving the profitability of private brands.

08:43 EDT J.C. Penney: Response to Biggest Sale of Them All exceeded expectations

08:41 EDT J.C. Penney: August comps negative, strong positive comps in September, October

08:39 EDT Halozyme to present nonclinical data on PEGPH20 at SITC meeting - Halozyme will present nonclinical data at the 32nd Annual Meeting of the Society for Immunotherapy of Cancer, SITC, which demonstrate the potential for PEGPH20, Halozyme's pegylated recombinant human hyaluronidase, to increase the infiltration of immune cells into the tumor microenvironment and enhance the efficacy of immuno-oncology drugs in an HA-accumulating murine colon tumor model. The study shows that degradation of hyaluronan in a tumor by PEGPH20 can facilitate an anti-tumor immune response induced by checkpoint blockade by promoting effector cell infiltration and skewing the immune microenvironment toward a more anti-tumor composition. The data support Halozyme's ongoing clinical evaluation of PEGPH20 in combination with checkpoint inhibitors.

08:37 EDT J.C. Penney CEO: Women's apparel delivered positive comp in October - Chairman and CEO Marvin Ellison said on the company's Q3 earnings conference call that J.C. Penney took "the bold but necessary step" to liquidate apparel inventory in an effort to accelerate a wider transformation of the women's department. Following this reset, Ellison said the retailer saw improved performance in the women's division, "confirming these actions were necessary to drive growth in this high-volume apparel division." Ellison noted that women's apparel delivered a positive comp for the month of October "even when you remove the benefits of the accelerated clearance sales." "At this stage of our turnaround, we are committed to making decisions that benefit the long-term financial health of the company," Ellison said. Appliance sales more than doubled versus Q3 of last year, he added. J.C. Penney is up nearly 15% in premarket trading.

08:21 EDT CAE down 1.1% after reporting quarterly results

08:13 EDT ProPhase announces intention to commence tender offer to repurchase 1.7M shares - ProPhase Labs announced that it intends to commence a tender offer to purchase up to 1.7M shares of its common stock at a price per share of $2.30 per share. The company anticipates that the tender offer will be launched on or before November 20 and will remain open for at least 20 business days from initiation. If the maximum number of shares to be purchased in the tender offer were in fact tendered, the number of shares that would then be purchased in the tender offer represents approximately 13.7% of ProPhase's currently issued and outstanding common shares. If stockholders tender more than 1.7M shares, the maximum sought in the tender offer, ProPhase will purchase shares from all stockholders who properly tender shares, on a pro rata basis, based on the aggregate number of shares tendered. The NASDAQ Official Closing Price of ProPhase's common stock on November 9, 2017 was $2.11 per share. ProPhase has approximately $27.7M in cash and cash equivalents and investments, a portion of which will be used to fund the tender offer.

08:03 EDT Deckers Brands issues letter urging shareholders to vote for board nominees - Deckers Brands announced today that its Board of Directors is sending a letter to stockholders highlighting the board's confidence in its transformation strategy, which is further emphasized by the recently announced $400M stock repurchase authority. The letter says, "At our upcoming Annual Meeting of Stockholders on December 14, 2017, you will be asked to make an important decision regarding the future direction of our company and the value of your investment. Your Board of Directors and management team are transforming Deckers in order to win in this environment and meet the challenges posed by the sweeping changes in the retail and branded products industries. This transformation is already delivering increased stockholder value and positioning Deckers to create even more stockholder value in the future. We are confident in our future prospects, and our latest quarterly results and recently announced plan to repurchase $400M of our stock are strong signals that Deckers is on the right path. Despite the progress that we have made, Marcato Capital Management continues to persist in a distracting and expensive proxy contest to replace every current director and install its own slate of nominees on our Board, none of whom we have been allowed to meet. We believe that the election of Marcato's unvetted nominees will derail the progress and momentum that we have made, lead to executive departures and put the value of your investment in Deckers at risk. Your vote "FOR" ALL nine of Deckers' directors is a vote to continue a transformation strategy that is producing solid results. We urge you to vote today on the WHITE proxy card. Please simply disregard the Gold proxy card sent to you by Marcato."

08:02 EDT Legg Mason reports preliminary AUM $755.2B as of October 31

08:01 EDT Second Sight says OHTAC recommends public funding for Argus II system - Second Sight Medical Products announced that the Argus II Retinal Prosthesis System has been recommended for public funding by the Ontario Health Technology Advisory Committee of Health Quality Ontario. The recommendation has been forwarded to the Ontario Minister of Health and Long-Term Care. Will McGuire, President and CEO of Second Sight, said, "We are pleased that OHTAC has made this important decision to facilitate coverage of the Argus II in Ontario, which we believe will enable us to offer greater access to patients with RP and continue to fulfill our mission of providing useful vision to the blind."

07:38 EDT J.C. Penney reports Q3 SSS up 1.7% - CEO Marvin Ellison say: "We are encouraged that we delivered positive sales comps for the third quarter. Our growth strategies and new apparel initiatives led to sequential comp sales improvement in nearly all merchandise categories in the third quarter, giving us confidence that our overall strategy and transformation is beginning to take hold. While we have more work to do, we remain focused on two critical factors - to operate the business for growth and deliver positive earnings."

07:31 EDT Vertex receives CHMP positive opinion for Orkambi in children with CF - Vertex Pharmaceuticals announced that the European Union Committee for Medicinal Products for Human Use issued a positive opinion recommending extension of the Marketing Authorization for ORKAMBI to children with cystic fibrosis ages 6 through 11 who have two copies of the F508del mutation. There are approximately 3,400 patients ages 6 through 11 eligible for this medicine in Europe. The European Commission generally follows the recommendations of the CHMP and typically extends the Marketing Authorization within three months. In some countries, Vertex said it has in place existing agreements that will make ORKAMBI available to this age group immediately following Marketing Authorization. In other countries, Vertex will begin the country-by-country reimbursement process following Marketing Authorization.

07:29 EDT Amgen, Allergan receive positive CHMP opinion for ABP 215 - Amgen (AMGN) and Allergan (AGN) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the Marketing Authorization of ABP 215, a biosimilar to Avastin. ABP 215 has been recommended for approval for the treatment of certain types of cancer, including in combination with fluoropyrimidine-based chemotherapy for metastatic carcinoma of the colon or rectum; in combination with paclitaxel for metastatic breast cancer; in combination with platinum-based chemotherapy for unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer; in combination with erlotinib for unresectable advanced, metastatic or recurrent non-squamous NSCLC; in combination with interferon alfa-2a for advanced and/or metastatic renal cell cancer; in combination with carboplatin and paclitaxel, carboplatin and gemcitabine, and paclitaxel, topotecan, or pegylated liposomal doxorubicin for advanced, platinum-sensitive, or platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer; and in combination with paclitaxel and cisplatin, or alternatively, paclitaxel and topotecan for persistent, recurrent, or metastatic carcinoma of the cervix.

07:17 EDT Pfenex announces interim pharmacokinetic results from Study PF708-301 - Las night, Pfenex (PFNX) announced interim pharmacokinetic results from ongoing Study PF708-301, which compares the effects of PF708 and Forteo in osteoporosis patients. PF708 is a teriparatide product candidate that is being developed through the 505(b)(2) regulatory pathway in the US and references Forteo, marketed by Eli Lilly (LLY) for the treatment of osteoporosis patients at a high risk of fracture, as the Reference Listed Drug. Study PF708-301 completed enrollment in the third quarter of 2017 with a total of 181 patients - 90 randomized to PF708 and 91 to Forteo. The primary study endpoint is anti-drug antibody formation after 24 weeks of drug treatment. The secondary study endpoints are changes in bone mineral density and bone turnover markers after 24 weeks of drug treatment, as well as PK parameters for up to 4 hours after the first dose. The PF708 and Forteo PK profiles are comparable, and there are no statistically significant differences in key PK parameters. The study is on-track for completion and top-line immunogenicity data readout in the first half of 2018. Pfenex believes that results from Study PF708-301, along with the previously-announced bioequivalence findings from Study PF708-101 in healthy subjects, should satisfy the clinical filing requirements for PF708 and expects to submit the new drug application to the FDA in the third quarter of 2018. Pfenex believes it has sufficient cash resources to fund all necessary activities leading up to and including the submission of the NDA to the FDA.

07:10 EDT Ritchie Bros. sells over $44M of equipment in Houston - Ritchie Bros. sold more than 3,800 equipment items and trucks for $44M at its Houston, TX auction site. More than 4,900 people from 56 countries registered to bid in the two-day auction, including 3,350+ online bidders who purchased 56% of the equipment.

07:08 EDT Myriad Genetics enters collaboration with the VA - Assurex Health, a wholly-owned subsidiary of Myriad Genetics, announced that the Department of Veterans Affairs, or VA, recently initiated a national, multi-center trial to evaluate the company's GeneSight test to help improve health outcomes for veterans diagnosed with major depressive disorder, or MDD. Approximately 20% of the 2.6M veterans who deployed to Iraq or Afghanistan returned with MDD or a related mental health condition, and tragically suicide rates for veterans are twice that of the United States population. The study titled, PRIME Care, or PRecision Medicine In MEntal Health Care, is a randomized clinical trial to determine how providers use and patients respond to GeneSight-guided therapy. The VA has committed $12M to fund the study that will enroll 2,000 patients with MDD and include 250 healthcare providers at 21 VA medical centers. The study is expected to complete in 2021.

07:05 EDT Bristol-Myer says 'encouraging response observed' for Opdivo plus BMS-986205 - Bristol-Myers Squibb Company announced updated results for Opdivo plus BMS-986205, a selective, once-daily oral indoleamine 2,3-dioxygenase 1 inhibitor from the ongoing Phase 1/2a dose escalation and expansion study, CA017-003. In the dose escalation phase, the maximum tolerated dose of BMS-986205 in combination with Opdivo was 200 mg. Based on safety and pharmacodynamic data, the recommended dose for further study was determined to be 100 mg. In the dose expansion phase, findings for anti-tumor activity were reported in two cohorts - heavily pre-treated bladder and cervical cancer patients. In the bladder cancer cohort, the objective response rate and disease control rate were 32% and 44%, respectively. In the cervical cancer cohort, the ORR was 14% and DCR was 64%. The study also measured ORR by PD-L1 expression levels; in patients who express PD-L1 greater than or equal to1%, ORR was 46% and 25% in the bladder and cervical cancer cohorts, respectively. In patients who express PD-L1 less than1%, ORR was 22% in the bladder cancer cohort; no response was observed in cervical cancer patients. Response was observed regardless of prior lines of therapy. IDO1 is an enzyme that breaks down tryptophan, an essential amino acid which fuels cytotoxic T cells, to help regulate the immune system and avoid an over-response to threats. Some tumors express excessive amounts of IDO1 and deplete tryptophan, resulting in kynurenine production, which starves T cells of their fuel and prevents the immune system from responding appropriately to the cancer. Preclinical studies evaluating BMS-986205 suggest that targeting the IDO1 pathway in combination with other possible complementary immune pathways has the potential to more effectively activate the anti-tumor response. Early clinical data also show anti-PD-1 therapy may upregulate IDO1 expression in patients. The primary objectives of the dose escalation study are to establish the safety, tolerability, dose-limiting toxicity and maximum tolerated dose, maximum administered dose or alternate dose; BMS-986205 doses from 25 to 400 mg once-daily were evaluated in combination with Opdivo given 240 mg every two weeks. The secondary objectives in the dose escalation phase include pharmacokinetics, pharmacodynamics, immunogenicity and preliminary anti-tumor activity. The primary objective of the dose expansion phase is to investigate preliminary anti-tumor activity, as well as safety and tolerability with BMS-986205 in combination with Opdivo. In this portion of the study, patients received BMS-986205 100 or 200 mg orally QD in combination with Opdivo 240 mg intravenously every two weeks, or 480 mg intravenously every four weeks. The study evaluated potency of BMS-986205 by measuring serum kynurenine, an immune-modulating metabolite produced by the IDO1 enzyme that potentially allows cancer cells to escape the immune response. In addition to the anti-tumor activity data presented at SITC, additional results included evidence of increased kynurenine inhibition in the blood, with 56% inhibition achieved at the 100 mg dose selected for further evaluation. Kynurenine was also evaluated in pre- and on-treatment tumor samples, with reductions of up to 100% noted. Proliferating CD8 positive T cells were also increased in the paired tumor samples from a range of tumor types, providing evidence of immunomodulation within the tumor microenvironment by an IDO1 inhibitor in combination with a PD-1 inhibitor. Across doses from 25 to 400 mg of BMS-986205 in combination with Opdivo, treatment-related Grade 3/4 toxicities occurred in 11% of patients. Those occurring in two or more participants included increased AST, increased ALT, anemia, autoimmune hepatitis, fatigue, pneumonitis, hepatitis, hyponatremia, hypophosphatemia and increased lipase. In the study, 1.4% of patients were discontinued due to study-drug toxicity.

07:03 EDT Alpine Immune Sciences presents preclinical data on vIgD platform at SITC - Alpine Immune Sciences announced immuno-oncology preclinical data characterizing the functional activity of molecules Alpine successfully generated from its variant immunoglobulin domain platform. Several novel immuno-oncology molecules were functionally active via multiple mechanisms of action, including the demonstration of tumor suppression in an animal model. The findings will be presented on Friday, November 10, in a poster session titled "Immune Modulation, Cytokines, and Antibodies" at the Society for Immunotherapy of Cancer's 32nd Annual Meeting in National Harbor, MD. Data include: Tri-specific vIgDs for treating cancer with a single domain capable of interacting with three different B7 family members. Depending on formatting, tri-specific vIgDs are potentially capable of agonizing CD28, blocking PD-L1, blocking CTLA-4, and/or depleting tumor cells and/or regulatory T cells. Initial formats investigated in an animal model of cancer demonstrated activity with tumor growth suppression. A dual ICOS/CD28 costimulatory vIgD fused with the HER2-targeting monoclonal antibody trastuzumab to provide immune stimulation in the tumor microenvironment. These V-mAbs demonstrated in vitro proof of principle for immune cell stimulation and proliferation in response to HER2-positive tumor cells. Multiple vIgD Fc fusions capable of targeting TIGIT and PD-1 while sparing CD226. These multi-checkpoint inhibitory molecules blocked checkpoint activity and improved IFN-gamma production by "exhausted" T cells.

07:02 EDT Avnet expands share repurchase program by $200M - Avnet announced that its Board of Directors approved an expansion of the company's current share repurchase authorization by $200M. Avnet now has approximately $500M available for share repurchases when combined with prior authorizations, and the latest authorization has no expiration date.

07:00 EDT Opus Bank reaches settlement proposal in class action lawsuit - Opus Bank has entered into a memorandum of understanding to settle the putative class action lawsuit pending in the U.S. District Court for the Central District of California, Schwartz v. Opus Bank. The parties agreed to settle the lawsuit for $17.0M and negotiate in good faith and execute a stipulation of settlement within 30 days of November 3. The settlement is expected to be fully funded by the Bank's insurance carriers. The settlement is not expected to have any effect on the Bank's consolidated statements of income and comprehensive income for the three and nine months ended September 30. The settlement must be approved by the Court.

06:37 EDT Baron says Tesla investment can jump 20 times in 10-15 years - Ron Baron said on CNBC that Tesla offers an opportunity to make 20 times his investment over the next 10-15 years. The famed investor noted he's owned Tesla for three years and has made $150M thus far.

06:27 EDT Canalys: iPhone 8 Plus out-ships iPhone 8 in Q3 - According to a new report from research firm Canalys, Apple's (AAPL) iPhone 7 was the world's best-shipping smartphone in Q3 2017, with 13.0 million units shipped. The iPhone 6s was a distant second, after an uptick that resulted in 7.9 million shipments. Samsung's (SSNLF) Galaxy J2 Prime was third, with 7.8 million shipped, while Oppo took fourth and fifth place, with its A57 and R11 shipping 7.8 million and 7.2 million units respectively. Apple's iPhone 8, which launched in mid-September, did not make the top five. Worldwide smartphone shipments reached 375.9 million, up 5.9% year on year. Apple shipped 46.7 million smartphones in Q3 2017. The new iPhone 8 and 8 Plus accounted for 11.8 million of these. This falls well short of its predecessor, the iPhone 7 line, which topped 14 million in its first quarter. But while Apple shipped 5.4 million units of the iPhone 8, it shipped 6.3 million of the larger iPhone 8 Plus. This makes the iPhone 8 Plus the first iPhone Plus model to out-ship its smaller sibling in a single quarter. "Shipments of older devices, such as the iPhone 6s and SE, saw an uptick in Q3," said Ben Stanton. "The iPhone 7 also shipped strongly after its price cut in September. Apple grew in Q3, but it was these older, cheaper models that propped up total iPhone shipments. Apple is clearly making a portfolio play here. With the launch of the iPhone X, it now has five tiers of iPhone and delivers iOS at more price bands than ever before. This is a new strategy for Apple. It is aggressively defending its market share, but it will not compromise its rigid margin structure to do so." Samsung shipped 82.8 million smartphones in Q3, 8.2% more than in Q3 2016. This was thanks to growth in its J-series, which did particularly well in India and the Middle East. Samsung's new Galaxy Note8 dispelled any remaining negative sentiment around the Note series, shipping a solid 4.4 million units. For a product line aimed at driving value, not volume, this was a positive result. Reference Link

06:16 EDT Ford, Ekso Bionics announce partnership for upperbody exoskeletal tool - Ford said in a statement: "Putting dishes on a high shelf or changing an overhead lightbulb occasionally might not be difficult, but could you imagine performing either of these tasks 4,600 times per day? How about 1 million times a year?These are the approximate number of times some Ford assembly line workers lift their arms during overhead work tasks. At this rate, the possibility of fatigue or injury on the body increases significantly. But a new upper body exoskeletal tool - the result of a partnership between Ford and California-based Ekso Bionics - helps lessen the chance of injury. Called EksoVest, the wearable technology elevates and supports a worker's arms while performing overhead tasks. It can be fitted to support workers ranging from 5 feet tall to 6 feet 4 inches tall, and provides adjustable lift assistance of five pounds to 15 pounds per arm. It's comfortable to wear because it's lightweight, it isn't bulky, and it allows workers to move their arms freely. Designed and built for dynamic, real-world environments like factories, construction sites and distribution centers, the non-powered vest offers protection and support against fatigue and injury by reducing the stress and strain of high-frequency, long-duration activities that can take a toll on the body over time... With support from the United Automobile Workers and Ford, EksoVest is being piloted in two U.S. plants, with plans to test in other regions, including Europe and South America."

06:05 EDT Cambium Learning's ExploreLearning acquires content developer IS3D - Cambium Learning business unit ExploreLearning has acquired Athens, Georgia-based startup, IS3D, LLC, developers of Cogent Education Interactive Cases - online experiences that put students in the role of a STEM professional tasked with solving a real-world problem. Cogent's Interactive Cases provide contexts for learning difficult scientific concepts through authentic inquiry and problem solving. With initial availability by 2019, ExploreLearning plans to integrate Cogent Education resources into Gizmos, an online simulation library for grades 3-12 math and science. ExploreLearning also expects to retain the full Cogent development team, including the company's co-founder and CEO, Tom Robertson.

06:00 EDT TSMC reports October revenue up 3.8% from prior year - TSMC announced its net revenues for October 2017: On a consolidated basis, revenues for October 2017 were approximately NT$94.52B, an increase 6.7% from September 2017 and an increase of 3.8% from October 2016. Revenues for January through October 2017 totaled NT$794.40B, an increase of 2.3% compared to the same period in 2016.

05:57 EDT GOL Linhas reports Oct. traffic up 8.3% - GOL Linhas announces preliminary air traffic figures for the month of October. Comparisons refer to the same period of 2016. The total volume of GOL departures increased by 0.5% and the number of seats was up 0.3% in October, resulting in an increase in supply of 1.9%. GOL's load factor was 80.6% in October 2017, 4.6 p.p. up over the same period of 2016, due to a growth in demand of 8.1% in the period. In the domestic market, volume of departures and the number of seats increased by 0.5% and 0.4%, respectively over October 2016. In addition, GOL increased its supply by 1.7% in October over the same period the year before, while demand grew by 9.1%. GOL's Load factor was up 5.5 p.p. in comparison to the same month of the previous year, achieving 81.4%. In October, GOL's international market supply and demand rose by 3.9% and 0.3, respectively, reducing load factor by 2.7 p.p. in relation to the same period of 2016.

05:50 EDT New York REIT enters into contract to sell 333 W 34th Street property - New York REIT announced that it has entered into a contract to sell its property located at 333 West 34th Street, in New York, New York for $255M to real estate funds managed by Brookfield. The consummation of the sale is subject to customary closing conditions for sales of real property in New York, New York. The closing is expected to occur prior to year-end.